BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE,FIXATION,BONE

    MDR report key: 6517921 · Received April 25, 2017

    Report

    Report Number
    2520274-2017-11469
    Event Type
    Malfunction
    Date Received
    April 25, 2017
    Report Date
    March 28, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WILLIKSEN, JOHN H., ET.AL, (2013). VOLAR LOCKING PLATES VERSUS EXTERNAL FIXATION AND ADJUVANT PIN FIXATION IN UNSTABLE DISTAL RADIUS FRACTURES: A RANDOMIZED CONTROLLED STUDY. JOURNAL OF HAND SURGERY (JHS) VOLUME 38A, PAGE 1469 - 1476. THIS REPORT IS FOR UNKNOWN 2.4 LCP DISTAL RADIUS PLATE (18 TOTAL PLATES INVOLVED)/ QUANTITY 15 (UNKNOWN WHICH PLATES) OF 18 / LOT # UNKNOWN. UNKNOWN PART NUMBER, UDI UNAVAILABLE. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: WILLIKSEN, JOHN H., ET.AL, (2013). VOLAR LOCKING PLATES VERSUS EXTERNAL FIXATION AND ADJUVANT PIN FIXATION IN UNSTABLE DISTAL RADIUS FRACTURES: A RANDOMIZED CONTROLLED STUDY. JOURNAL OF HAND SURGERY (JHS) VOLUME 38A, PAGE 1469 - 1476. (NORWAY) THE PURPOSE OF THIS ARTICLE IS TO DETERMINE WHETHER VOLAR LOCKING PLATES (VLP) ARE SUPERIOR TO EXTERNAL FIXATION (EF) WITH ADJUVANT PINS IN THE TREATMENT OF UNSTABLE DISTAL RADIUS FRACTURES. A TOTAL OF 111 PATIENTS RECEIVED THEIR ALLOCATED INTERVENTION, WITH 59 IN THE EF GROUP AND 52 IN THE VLP GROUP. THERE WERE 22 MEN (20%) AND 89 WOMEN (80%). THE MEAN AGE WAS 54 YEARS (RANGE, 20¿84 Y), AND 20 PATIENTS WERE OLDER THAN 65. AT 52 WEEKS, 104 FRACTURES (94%) WERE CLINICALLY FOLLOWED UP. TWO PATIENTS WITHDREW FROM THE STUDY¿ONE WITH A SERIOUS COMPLICATION (COMPLEX REGIONAL PAIN SYNDROME); 2 PATIENTS DIED DURING THE FOLLOW-UP PERIOD FROM CAUSES NOT RELATED TO THEIR FRACTURES, AND 2 PATIENTS WERE LOST TO FOLLOW-UP. A TOTAL OF 104 PATIENTS REMAINED IN THE STUDY FOR THE FINAL ANALYSIS AT 52 WEEKS. AN EXTERNAL DISTAL RADIUS FIXATOR FROM SYNTHES (OBERDORF, SWITZERLAND) WAS USED IN 2. TWO PINS WERE INTRODUCED IN THE SECOND METACARPAL BY STAB INCISIONS, AND 2 PINS IN THE RADIUS THROUGH A 2¿4 CM INCISION. THREE ADJUVANT STEINMANN 1.8-MM PINS WERE USED IN ALL CASES, 2 FROM THE RADIAL SIDE AND 1 FROM THE ULNAR SIDE. THE EXTERNAL FIXATOR AND ADJUVANT PINS WERE REMOVED 6 WEEKS AFTER SURGERY. THE SURGICAL EXPOSURE OF THE FRACTURE WAS PERFORMED THROUGH THE FLEXOR CARPI RADIALIS APPROACH. THE FRACTURE WAS REDUCED AND SECURED WITH A VLP. THREE DIFFERENT PLATES WERE USED: 28 ACUMED ACU-LOC, 18 SYNTHES 2.4 LOCKING COMPRESSION PLATE (LCP) DISTAL RADIUS SYSTEMS (OBERDORF, SWITZERLAND), AND 6 HAND INNOVATION DVRS. A DORSAL PLASTER ORTHOSIS WAS USED FOR 2 WEEKS. COMPLICATIONS: - ONE PATIENT HAD A FIXATION FAILURE AND HAD TO CHANGE TO A VLP AT 6 WEEKS. - PATIENTS HAD PAIN OVER ULNAR STYLOID - THREE PATIENTS HAD INCOMPLETE REDUCTIONS - EIGHT PLATES WERE REMOVED DUE TO COMPLICATIONS DURING FIRST YEAR, SIX WERE RELATED TO SURGICAL ERRORS. THIS LITERATURE ARTICLE REPORTED A TOTAL OF 18 UNKNOWN SYNTHES PLATE. OF THE 18 UNKNOWN PLATES, 12 UNKNOWN PLATES INVOLVED UNKNOWN PATIENTS WITH SERIOUS INJURIES AND 1 UNKNOWN PATIENT WITH A DEVICE MALFUNCTION. ADDITIONALLY, THERE WERE 2 UNKNOWN PATIENTS WHO DIED OF UNRELATED CAUSES. THIS REPORT IS ONE 13 OF 13 OF 15 FOR (B)(4). THIS REPORT IS FOR UNKNOWN 2.4 LCP DISTAL RADIUS SYSTEMS INVOLVING A PATIENT WHO EXPERIENCED IMPLANT FAILURE AND WAS REVISED TO A VLP SYSTEM. THIS REPORT IS FOR 1 DEVICE. THIS COMPLAINT IS BEING LINKED TO (B)(4), WHICH REPORTED ON AO FIXATOR AND ADDITIONAL FOLLOW-UP RESULTS IN 2015. THIS COMPLAINT ADDRESSES THE 2.4 LOCKING COMPRESSION PLATE (LCP) DISTAL RADIUS SYSTEMS AND THE STUDY RESULTS IN 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299496 PLATE,FIXATION,BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1